Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.
Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma|
- To determine if high rates of local control can be maintained after a reduction in the RT dose and volume after 4 to 6 cycles of rituximab containing chemotherapy. [ Time Frame: 5 year ] [ Designated as safety issue: No ]This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the observed 5-year LC rate, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.
- Progression-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first.
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Overall survival will be defined as the time from on-study to death due to any case.
- To examine patterns of failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.
Radiation: Radiation Therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186978
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Christopher Kelsey, MD 919-668-5213 firstname.lastname@example.org|
|Principal Investigator: Christopher Kelsey, MD|
|Durham Regional Hospital||Recruiting|
|Durham, North Carolina, United States, 27704|
|Contact: Bridget Koontz, MD 919-470-8600|
|Principal Investigator: Bridget Koontz, MD|
|Duke Raleigh Hospital||Enrolling by invitation|
|Raleigh, North Carolina, United States, 27609|
|Principal Investigator:||Christopher Kelsey, MD||Duke University Medical Center, Radiation Oncology|